Maintenance Therapy With Oral Azacitidine in AML
Posted: Wednesday, March 25, 2020
According to the QUAZAR AML-001 trial, the investigational form of azacitidine, CC-486, can be used in the maintenance setting to provide statistically and clinically meaningful improvements in overall and relapse-free survival for patients with acute myeloid leukemia (AML) in remission after standard induction therapy. Andrew H. Wei, MBBS, FRACP, FRCPA, PhD, of Alfred Hospital, Melbourne, presented these findings on behalf of his colleagues at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract LBA3), which also published in the journal Blood.
“The AML community has been trying to validate the role of maintenance therapies to extend initial treatment responses for many decades and—until now—without success,” said Dr. Wei in an ASH press release. “The QUAZAR [study] shows that, rather than observing patients and waiting for them to relapse, we can now actively engage in trying to reduce relapse risk and improve survival in the post-remission phase.”
The trial enrolled 472 patients with AML between the ages of 55 and 86 who had achieved a complete response or a complete response with incomplete count recovery after induction chemotherapy with or without consolidation. Patients were randomly assigned to receive either 300 mg of CC-486 or placebo once a day for 14 days of a 28-day cycle.
Overall survival was improved by 31% for patients receiving CC-486 versus placebo, at a median follow-up of 41.2 months. The median overall survival was 24.7 months with C-486 compared with 14.8 months with placebo. Relapse-free survival in the CC-486 arm was 10.2 months, compared with 4.8 months in the placebo arm (hazard ratio = 0.65). These benefits were seen in patients regardless of the baseline cytogenetic risk, the number of prior consolidation cycles received, and complete response status.
Frequently reported adverse events with CC-486 and placebo included grade 1 or 2 gastrointestinal events such as nausea, vomiting, and diarrhea. Common grades 3 and 4 adverse events in the CC-486 population included neutropenia, thrombocytopenia, and anemia.
Disclosure: For full disclosures of the study authors, visit ashpublications.org.